Can you accept the EVAR Trials 10-year results and still justify EVAR for all-comers? Janet Powell Imperial College London
Questions to be addressed What did the analyses show? Is continued enthusiasm for EVAR technology justified if we accept this high quality evidence? Is there a place for patient selection based on risk assessment?
The EVAR randomised trials for elective AAA repair All had selective recruitment: not all-comers Predated widespread screening, so large AAAs AAA diameter ≥5 or 5.5cm EVAR-2 Fit for either treatment Within IFU Age 50+ year, ~90% men AAA ≥ 5,5cm Recruiting 1999-2008 Unfit for open repair Within IFU 4 trials Randomised to early EVAR In Europe/USA Open repair or no intervention EVAR EVAR-1 OVER DREAM ACE
The EVAR 2 trial for those unfit for open repair Aneurysm-related 100 mortality EVAR 80 No HR = 0.46; intervention p=0.019 60 All-cause mortality EVAR 40 HR = 1.07; No intervention 20 p=0.52 0 0 2 4 6 8 10 12 Years since Randomization • Lower aneurysm-related mortality: HR=0.46; p=0.02 Number at risk • No benefit in terms of total mortality: HR=1.07; p=0.52 Endovascular repair 197 127 81 59 31 18 6 • No repair 207 137 80 51 38 25 15 7% survival probability at 12-years • Unfit patients, never any survival benefit from EVAR: cost burden
The EVAR 1 trial of EVAR vs open repair in fit patients within IFU: Survival over 15 years 100 AAA-related mortality 80 Percentage Surviving 60 Open 40 Endovascular-repair aneurysm-related survival, 0.830 (0.762, 0.880) EVAR Open-repair aneurysm-related survival, 0.879 (0.764, 0.940) 20 Endovascular-repair survival from any cause, 0.148 (0.103, 0.199) Showed the same & Open-repair survival from any cause, 0.238 (0.194, 0.284) more reinterventions in EVAR group 0 0 2 4 6 8 10 12 14 Years since Randomization Number at risk Lancet 2016 Endovascular repair 626 543 474 409 339 263 135 41 Open repair 626 534 464 399 333 257 143 50
Decreasing cost-effectiveness of EVAR vs open repair after 10 years: why? After 10 years <50% patients remain alive • Increasing mortality NASTY Increased secondary rupture & aneurysm-related mortality Increased risk of abdominal cancer & deaths from cancer • Increasing costs NASTY More surveillance & increasing numbers of re-interventions
The fading promise of EVAR: blamed on old technology Unlikely
Device modifications have extended EVAR-eligibility: no guarantee newer devices will perform better: NASTY! • Lifetime of devices needs to be 20 years • Increasing use of low profile devices: the fabric is subject to compression- induced crimping & wrinkling: increased risk of tears & porosity • Despite improvements in the purity of nitinol, supports still liable to fractures with time But, better imaging should allow for more accurate placement
2 Unsolved or insoluble contributors to EVAR failure NASTY Proximal seal in regions of unidentified aortic disease Progression of aneurysmal disease over time Poor compliance with surveillance
Who wants EVAR? 2 Is there still enthusiasm for EVAR? √√√ Patients EVAR is here to stay √√ Clinicians So it has to get better, with appropriate patient selection √√√√ Industry
Precision medicine, for patients exiting NAAASP 3 Treatment based on risk assessment EVAR Open repair Defer 68 years, married 75 years, married 74 years, divorced AAA 5.6 cm AAA 5.5 cm AAA now 6.3 cm Sedentary lifestyle Keen golfer Emigrating to Spain? Smoker, recent MI Morphology within IFU Morphology close to IFU Morphology not quite IFU Compliant with BP drugs Defaulted from surveillance
Although EVAR cannot be justified in all-comers, there is a future for EVAR • Learn from history • Careful selection of fit patients • Address the NASTY issues • Better devices Non-metallic fixation, more applicable to women, more durable, inbuilt sensors for early remote warning of problems
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